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Naproxen Rx-to-OTC switch

This article was originally published in The Tan Sheet

Executive Summary

FDA approval of Syntex/P&G's application to market naproxen sodium as an over-the-counter analgesic is expected this month. Although a joint meeting of FDA's Nonprescription Drugs Advisory Committee and Arthritis Advisory Committee voted not to recommend approval on June 2, FDA Office of OTC Drug Evaluation Director Michael Weintraub indicated at a Sept. 8 meeting of the two committees that the agency was preparing to override the vote ("The Tan Sheet" Sept. 13, p. 8) The application is understood to be in the final stages of review at FDA.
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